Catheter unit for cholangiography

ABSTRACT

A catheter unit for use in operative cholangiography comprising a transparent elongated conduit member having a rounded, open distal end for insertion into the biliary tree and an open proximal end, and a transparent adapter in leak-proof engagement with the conduit member adjacent its proximal end. The adapter includes a recess communicating with the proximal end whereby a source of fluid may be placed in the recess for the transmittal of fluid to the conduit member. The conduit member includes a smoothly rounded enlargement set back from the distal end a distance of between about 3/16 inch and about one inch whereby, when the enlargement is located in the cystic duct of a patient, the distal end will be located in the common duct.

United States Patent [191 Patel [4 1 Nov. 11,1975

[ l CATHETER UNIT FOR CHOLANGIOGRAPHY [52] US. Cl 128/348; 128/348 X[51] Int. Cl. A61M 25/00 [58] Field of Search 128/348-350,

128/295, 2 F, DIG. 24

[56] References Cited UNITED STATES PATENTS 3.358.684 13/1967 Marshall128/348 X 3.695921 10/1972 Shepherd et al 128/348 FOREIGN PATENTS ORAPPLICATIONS 705.681 3/1965 Canada 128/348 Prinmry Examiner-Lawrence W.Trapp l5 7] ABSTRACT A catheter unit for use in operativecholangiography comprising a transparent elongated conduit member havinga rounded, open distal end for insertion into the biliary tree and anopen proximal end, and a transparent adapter in leak-proof engagementwith the conduit member adjacent its proximal end. The adapter includesa recess communicating with the proximal end whereby a source of fluidmay be placed in the recess for the transmittal of fluid to the conduitmember. The conduit member includes a smoothly rounded enlargement setback from the distal end a distance of between about 3/16 inch and aboutone inch whereby, when the enlargement is located in the cystic duct ofa patient, the distal end will be located in the common duct.

5 Claims, 3 Drawing Figures US. Patent Nov. 11, 1975 3,918,456

FIG I v CATHETER UNIT FOR CHOLANGIOGRAPHY BACKGROUND OF THE INVENTIONThis invention relates to a medical device for use in operativecholangiography.

Operative cholangiography is the x-ray visualization of the biliarysystem of a patient during an operation (typically, removal of thegallbladder). During a gallbladder removal procedure.(i.e.,cholecystectomy) the surgeon typically attempts to determine thepresence of stones in the duct system exclusive of the gallbladderitself. Stones in the common bile duct (i.e., the duct formed by theconfluence of the cystic duct and the hepatic duc't), 'however, aretypically difficult to detect by mere palpation. On the other hand,surgical intervention into the common duct may itself be a frequentsource of p'ost-cholecystectomy morbidity, just as overlooked stones maybe, and thus is not routinely recommended absent an indication of thepresence of stones. Cholangiography is of assistance in thiscircumstance and involves the injection of a radio-opaque dye into thebiliary system and the subsequent x-ray visualization of the biliaryducts to determine thepresence of stones or other blockages.

Despite" the evident value of cholangiography, its use as a routinematter'has been greatly restricted because of-the difficulty inmanipulating, and otherwise properly employing,-' the implementspreviously proposed for supplying the dye to'the biliary system. Theseprior art devices have included rigid needles incorporating a bulgewhich cooperates with a'modified hemostat to retain thei'needle withinthe cystic duct; flexible catheters having regions of increased frictionnear the distal end to serve as a locus for a ligature tied around thecystic duct; flexiblecatheters having an exterior formation immediatelyadjacent the distal end providing a shoulder-which cooperates with aligature tied to the cystic duct to inhibit unwanted withdrawal of thecatheter from the duct; etc.

Each of the prior devices, including'those just mentioned, suffers-fromone or more of various drawbacks which have contributed tothedissatisfaction of many surgeons with operative cholangiography as aroutine procedure duringa cholecystectomy. These problems includeimplement designs which can cause damage to internal tissue in thebiliary system; difficulty, or even inability, to properly locate thedistal end of the dye delivering implement to obtain maximumdistribution of the dye in the common duct; the difficulty in manuallylocating, after the implement has entered the cystic duct, the exactlocation of a ligature receiving formation on the implement; the use ofexpensive materials which render the implement non-disposable; theprovision of implements which are not adequately visually andradio-transparent; and the provision of implements in which the diameterof the conduit for the dye changes intermediate the distal and proximalends of the implement. It is to be understood that various of thesedefects of prior implements have been discovered according to thepresent invention rather than being evident problems requiring solution.Typically, only broadly stated defects have heretofore been recognized(e.g., the implement would prematurely slip out of the cystic duct orthe x-ray results were misleading or ambiguous).

In view of the foregoing, it is a principle object of the presentinvention to provide an improved implement for use in operativecholangiography which facilitates the insertion, orientation, andretention of the implement in the appropriate body cavity. Morespecifically, it is an object to provide an implement which overcomesthe various specific problems, listed above,

which have been identified according to the present invention.

SUMMARY OF THE INVENTION To achieve these and other objects, as shallfurther appear, there is provided according to the invention a catheterunit for use, in operative cholangiography which comprises a transparentelongated conduit member having a founded open distal end for insertioninto a body cavity and an open proximal end. The unit also comprises atransparent adapter in leak-proof engagement with the conduitmember'adjacent that members proximal end. The adapter includes a recesscommunicating with the conduit member proximal end, whereby a source offluid may be placed in that recess for the transmittal of fluid to theconduit member. The conduit member includes a smoothly roundedenlargement set back from its :distal end a distance of between-about3/16 inch and about 1 inch, whereby, when the enlargement is located inthe cystic duct of a patient, the distal end will be located in thecommon duct of the patient. Preferably, the enlargement comprises anintegral head around the exterior of the conduit member; the enlargementis located approximately inch from the distal end; the conduit memberincludes a substantially rigidtip portion extending from thedistal endto at least a location of the enlargement and the remainder of theconduit member is flexible; and the adapter is bonded to the exteriorsurface of the conduit member thereby avoiding a reduction in thediameter of the conduit through which the fluid passes.

BRIEF DESCRIPTION OF THE DRAWING Other objects, features, and advantagesof the invention will appear'from the following description ofaparticular preferred embodiment, taken together with th accompanyingdrawing. In the drawing:

FIG. lis a partly broken away perspective view of a catheter unit foruse in operative cholangiography constructed according to the presentinvention;

FIG. 2 is an enlarged sectional view of a portion of the catheter unitof FIG. 1 adjacent the distal end thereof; and

FIG. 3 is a partly broken away side elevation of the distal portion ofan alternative embodiment.

DETAILED DES CRIPTION OF A PARTICULAR PREFERRED EMBODIMENT Referring tothe drawing, the catheter unit 10 comprises a transparent conduit member12 and a transparent adapter 14. The adapter 14 is bonded to theproximal end 16 of the conduit member around the exterior thereof. Arecess 18 within the adapter 14 communicates with the distal end 16 ofthe conduit member and is sized and shaped to receive a standard syringeluer. The conduit member 12 is generally flexible but may include aportion 20 of less flexibility adjacent the distal end 22.(Alternatively a separate rigid molded tip member 23 (FIG. 3) may besecured to the flexible conduit member.) A smoothly rounded enlargement24 is provided on the member 12. The enlargement is pref erably in theform of a molded or bonded bead of substantially the diameter ofa cysticduct and formed from the same plastic material (of any conventionaltype) which forms the body of the conduit member 12. The enlargement 24is set back from the distal end 22 a distance of between about 3/16 inchand about 1 inch, preferably about inch. The conduit member 12 has asmoothly rounded profile, as at 26, immediately adjacent the distal end22.

In operation, after the surgeon has exposed the gallbladder and cysticduct, an incision is made in the cystic duct and the distal end of theconduit member is inserted through the incision and the conduit memberpushed into the duct until the enlargement 24 can be felt to be lodgedin the cystic duct adjacent its intersection with the common duct. Whenin that location, owing to the set back of the enlargement from thedistal end 22, the distal end will be positively positioned within thecommon duct for ultimate distribution of dye to the common duct. Aligature is then tied around the cystic duct behind the enlargementwhich serves the additional purpose of cooperating with the ligature toretain the conduit member in place. In embodiments which include themore rigid tip portion of the catheter, this feature facilitates theworking of the catheter past the spiral valves present in the cysticduct and the prevention of conduit collapse due to the ligature. Alsothe presence of the bead prevents the retrograde of the dye.

Since the conduit member 12 and the adapter 14 are conventionally filledwith saline solution prior to insertion into the biliary system, thetransparency of those elements provides for a convenient and positivedetermination of the presence or absence of air bubbles within thesolution. Such air bubbles, if injected into the common duct, can beinterpreted to be stones in the ultimate cholangiogram and are thus mostundesirable. After the ligature has been tied the luer of a syringecontaining the dye is inserted into the recess of the adapter and thedye is forced into and through the conduit member 12. The dye thusenters the common duct of the patient and an x-ray may then be taken.Withdrawal of the conduit member from the duct system and removal of thegallbladder can proceed in a conventional fashion.

Owing to the bonding of the adapter 14 to the exterior of the conduitmember 12 rather than providing an adapter or needle for insertion intothe conduit memher, a constant cross section of the conduit throughwhich the dye will flow is assured and, thus, there will be no pressurechanges as the dye passes through the adapter and conduit member. Suchpressure changes, which will occur with certain prior art constructions,can be misinterpreted by the surgeon as indicating a resistance to theflow of dye after it has passed from the distal end 22 of the conduitmember, and, thus, an indication of the presence of stones or otherblockages in the biliary system. Additionally, inadvertent leakage ofthe junction is prevented as might be found in separable attachments.

While a particular preferred embodiment has been illustrated in thedrawing and described in detail herein, other embodiments, of course,are within the scope of the invention and the following claims.

I claim:

1. A catheter unit for use in operative cholangiography comprising atransparent elongated conduit member having a rounded, open distal endfor insertion into a body cavity and an open proximal end, and atransparent adapter in leak-proof engagement with said conduit memberadjacent said proximal end, said adapter including a recesscommunicating with said proximal end whereby a source of fluid may beplaced in said recess for the transmittal of fluid to said conduitmember, said conduit member including a smoothly rounded enlargementthereof set back from said distal end, a distance of between about 3/16inch and about one inch, whereby when said enlargement is located in thecystic duct of a patient said distal end will be located in the commonduct of the patient.

2. A catheter unit as claimed in claim 1 wherein said enlargementcomprises an integral bead around the exterior of said conduit member.

3. A catheter unit as claimed in claim 1 wherein said enlargement islocated approximately inch from said distal end.

4. A catheter unit as claimed in claim 1 wherein said conduit memberincludes a substantially rigid tip portion extending from said'distalend to at least the location of said enlargement.

5. A cathether unit asclaimed in claim 1 wherein said adapter is bondedto the exterior surface of said conduit member.

1. A catheter unit for use in operative cholangiography comprising atransparent elongated conduit member having a rounded, open distal endfor insertion into a body cavity and an open proximal end, and atransparent adapter in leak-proof engagement with said conduit memberadjacent said proximal end, said adapter including a recesscommunicating with said proximal end whereby a source of fluid may beplaced in said recess for the transmittal of fluid to said conduitmember, said conduit member including a smoothly rounded enlargementthereof set back from said distal end, a distance of between about 3/16inch and about one inch, whereby when said enlargement is located in thecystic duct of a patient said distal end will be located in the commonduct of the patient.
 2. A catheter unit as claimed in claim 1 whereinsaid enlargement comprises an integral bead around the exterior of saidconduit member.
 3. A catheter unit as claimed in claim 1 wherein saidenlargement is located approximately 3/8 inch from said distal end.
 4. Acatheter unit as claimed in claim 1 wherein said conduit member includesa substantially rigid tip portion extending from said distal end to atleast the location of said enlargement.
 5. A cathether unit as claimedin claim 1 wherein said adapter is bonded to the exterior surface ofsaid conduit member.